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FDA 510(k)

Concerto Versa, Detachable Coil

K-Number: K202850 · 2021-02-09

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2021-02-09
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Concerto Versa, Detachable Coil is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2021-02-09 under 510(k) number K202850. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Concerto Versa, Detachable Coil?

Concerto Versa, Detachable Coil is a medical device that received FDA 510(k) clearance on 2021-02-09. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K202850.

When did Concerto Versa, Detachable Coil receive FDA 510(k) clearance?

Concerto Versa, Detachable Coil received FDA 510(k) clearance on 2021-02-09, under 510(k) number K202850.

Who is the listed applicant for Concerto Versa, Detachable Coil?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concerto Versa, Detachable Coil?

The FDA product code for Concerto Versa, Detachable Coil is KRD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07639853Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable CoilsENROLLING_BY_INVITATION

Other records listing Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as applicant

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Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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